Patients who switched from ozanimod HCI 0.5 mg or interferon β-1a to ozanimod HCI 1.0 mg in an open-label extension study experienced sustained reduction in their annualized relapse rate. Patients who continued on with the 1.0 mg dose also experienced a sustained reduction.
Patients with relapsing multiple sclerosis (MS) who had long-term use of ozanimod HCI had a sustained reduction in their annualized relapse rate (ARR), according to research published at the 2019 American Academy of Neurology Annual Meeting.
The patients studied were participants of 2 phase 3 trials: RADIANCE and SUNBEAM. These were randomized, double-blind studies that included a dose-escalation period followed by treatment of once-daily oral ozanimod HCI 0.5 or 1.0 mg or weekly intramuscular interferon (IFN) β-1a 30 μg. In SUNBEAM, the patients received treatment for 12 months or longer, while RADIANCE treated patients for 24 months. After completing the trials, patients were eligible to enroll in DAYBREAK, an open-label extension (OLE) study.
The study published results of the ongoing DAYBREAK trial with a mean duration follow-up of 18.5 months. Participants who had been treated with IFN in the parent trial and those who had more than 14 days pass between their last dose of ozanimod and the first dose in the OLE had ozanimod HCI initiated with dose escalation over 7 days.
A total of 2257 patients entered the OLE. Their average age was 37.3 years old at the time of entry; a majority were female (66.5%) and white (99.4%); and the mean time from onset of MS symptoms was 6.8 years.
All patients—those who continued ozanimod HCI 1.0 mg and those who switched from ozanimod 0.5 mg and IFN in the parent trials—exhibited sustained reduction in ARR. Among the patients who were on IFN in the parent trial, the adjusted ARR was 0.25, which dropped to 0.13 when they switched to ozanimod HCI 1.0 mg in the OLE. Patients taking ozanimod HCI 0.5 mg in the parent trial had an adjusted ARR of 0.18 that fell to 0.13 in the OLE. Patients taking ozanimod HCI 1.0 mg in the parent trial had an adjusted ARR of 0.15 that further fell to 0.13 in the OLE.
The rate of discontinuation in the OLE was 6.4% with 0.9% due to adverse events. Rates of any treatment-emergent adverse event (TEAE) on ozanimod were similar in the parent trials and in the OLE. For patients on IFN in the parent trial the rate of any TEAE dropped from 79.2% to 70.1% after switching to ozanimod. The most frequent TEAE in the OLE was nasopharyngitis, which occurred in 12.8% of patients who switched from IFN, 11.1% of patients who switched from ozanimod HCI 0.5 mg, and 10.6% of patients who stayed on ozanimod HCI 1.0 mg.
Steinman L, Comi G, Cree BAC, et al. Ozanimod efficacy in relapsing multiple sclerosis supported by open-label long-term extension of two phase 3 trials. Presented at: American Academy of Neurology 2019 Annual Meeting; May 4-11, 2019; Philadelphia, Pennsylvania. Abstract S2.036.